Nebilet - instructions for use, analogs, reviews and release forms (5 mg tablets) drugs for the treatment of hypertension (pressure reduction) and prevention of angina attacks in adults, children and pregnancy. Composition and interaction with alcohol

In this article, you can read the instructions for using the drug Non-ticket. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Nebilet in his practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Nebiletov Analogues in the presence of existing structural analogues.Use for the treatment of hypertension (pressure reduction) and prevention of angina attacks in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Non-ticket - Cardioselective beta-1 blocker. Has antihypertensive, anti-anginal and antiarrhythmic effect. Reduces elevated blood pressure at rest, with physical stress and stress. Competitively and selectively blocks postsynaptic beta 1-adrenergic receptors, making them inaccessible to catecholamines, modulates the release of the endothelial vasodilating factor of nitric oxide (NO).

Nebivolol (the active substance of Nebilet) is a racemate of two enantiomers: SRRR-nebivolol (D-nebivolol) and RSSS-nebivolol (L-nebivolol), combining two pharmacological actions:

• D-nebivolol is a competitive and highly selective beta 1-adrenergic blocker;
• L-nebivolol has a mild vasodilating effect due to the modulation of the release of the vasodilating factor (NO) from the vascular endothelium.

The hypotensive effect is also due to a decrease in the activity of the renin-angiotensin system (does not directly correlate with a change in renin activity in the blood plasma).

A stable hypotensive effect develops after 1-2 weeks of regular intake of the drug, and in some cases - after 4 weeks, a stable effect is observed after 1-2 months.

Reducing the need for myocardium in oxygen (decreasing heart rate and reducing preload and afterload), reduces the number and severity of angina attacks and increases the tolerance of exercise.

Antiarrhythmic effect due to suppression of pathological automatism of the heart (including in the pathological focus) and slowing AV-conduction.

Composition

Nebivolol hydrochloride micronized + excipients.

Pharmacokinetics

After oral administration, both enantiomers are rapidly absorbed. The intake of food does not affect absorption, so the Nebilet can be taken regardless of the meal. Bioavailability of nebivolol after ingestion averages 12% in persons with fast metabolism (the effect of first passage through the liver) and is almost complete in individuals with slow metabolism. It is excreted by the kidneys (38%) and through the intestines (48%). Elimination of unchanged nebivolol with urine is less than 0.5% of the amount taken internally.

Indications

• arterial hypertension;
• ischemic heart disease: prevention of angina pectoris attacks;
• chronic heart failure (as part of combination therapy).

Forms of release

Tablets 5 mg.

Instructions for use and dosage

Tablets are taken orally, once a day, preferably always at the same time of the day, regardless of food intake, with a sufficient amount of liquid.

The average daily dose for the treatment of arterial hypertension and ischemic heart disease is 2.5-5 mg (1 / 2-1 tablets). A non-ticket can be used in monotherapy or in combination with other means that reduce blood pressure.

In patients with renal insufficiency, as well as in patients older than 65 years, the initial dose is 2.5 mg (1/2 tablets) per day. If necessary, the daily dose can be increased to a maximum of 10 mg (2 tablets in 1 dose).

Treatment of chronic heart failure should begin with a slow increase in the dose until an individual optimal maintenance dose is reached. Selection of the dose at the beginning of treatment should be carried out, while maintaining intervals of 1 to 2 weeks and based on the tolerance of this dose to the patient:component of 1.25 mg nebivolol (1/4 tablets) once a day can be increased first to 2.5-5 mg (1 / 2-1 tablets), and then to 10 mg (2 tablets) once a day.

The maximum recommended dose is 10 mg once a day.

At the beginning of treatment and at each dose increase, the patient should be under the supervision of a doctor for at least 2 hours to ensure that the clinical condition remains stable (especially, blood pressure, heart rate, conduction disorders, and symptoms of worsening of chronic heart failure).

Rules for the division of tablets

For division, place the tablet on a firm, level surface with a cross-shaped notch up, press the tablet with both index fingers. To obtain 1/4 tablets, repeat the same procedure with 1/2 tablet.

Side effect

• headache;
• dizziness;
• increased fatigue;
• weakness;
• paresthesia;
• depression;
• nightmarish dreams;
• confusion of consciousness;
• fainting;
• hallucinations;
• nausea, vomiting;
• constipation;
• diarrhea;
• dyspepsia;
• flatulence;
• bradycardia;
• acute heart failure;
• AV blockade;
• orthostatic hypotension;
• Raynaud's syndrome;
• skin rash of erythematous nature;
• itching;
• aggravation of psoriasis;
• angioedema;
• bronchospasm;
• dry eyes.

Contraindications

• acute heart failure;
• chronic heart failure in the stage of decompensation (requiring intravenous administration of drugs with inotropic effect);
• severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
• SSSU, including the sinoatrial blockade;
• AV-blockade of 2 and 3 degrees (without artificial pacemaker);
• bradycardia (heart rate less than 60 beats per minute);
• cardiogenic shock;
• pheochromocytoma (without simultaneous use of alpha-blockers);
• metabolic acidosis;
• severe liver dysfunction;
• bronchospasm and bronchial asthma in history;
• severe obliterating diseases of peripheral vessels (intermittent claudication, Raynaud's syndrome);
• myasthenia gravis;
• depression;
• lactose intolerance, lactase deficiency and glucose malabsorption / galactose syndrome;
• children and adolescents under 18 years of age (efficacy and safety not studied);
• hypersensitivity to nebivolol or one of the components of the drug.

Application in pregnancy and lactation

In pregnancy, the drug Nebilet is prescribed only for vital indications, when the benefit to the mother exceeds the possible risk to the fetus or newborn (due to possible fetal and newborn bradycardia, arterial hypotension, hypoglycemia). If treatment with Nebilet is necessary, then you need to monitor the utero-placental blood flow and fetal growth. Treatment should be interrupted for 48-72 hours before childbirth. In cases where this is not possible, it is necessary to establish strict observation of newborns within 48-72 hours after delivery.

Nebivolol is excreted in breast milk. If you need to take the drug Nebilet during lactation, breastfeeding should be discontinued.

special instructions

The abolition of beta-blockers should be carried out gradually within 10 days (up to 2 weeks in patients with ischemic heart disease).

Control of blood pressure and heart rate at the beginning of the drug should be daily.

Older patients need control of kidney function (1 time in 4-5 months).

With angina pectoris, the dose of the drug should provide a heart rate at rest within 55-60 beats / min, with a load - no more than 110 beats per minute.

Beta-adrenoblockers can cause bradycardia: the dose should be reduced if the heart rate is less than 50-55 bpm.

When deciding on the use of Nebilet in patients with psoriasis, the expected benefits of using the drug and the possible risk of exacerbation of psoriasis should be carefully correlated.

Patients using contact lenses should take into account that the use of beta-blockers may reduce the production of tear fluid.

Influence on reproductive function

In a two-year study of nebivolol in mice, there was a statistically significant increase in the incidence of hyperplasia of the testicular tissue and testicular adenoma when administered at a dose of 40 mg / kg per day (5-fold higher than the MPDM, 40 mg / m2).

When conducting surgical interventions, an anesthesiologist should be warned that the patient is taking beta-blockers.

Nebivolol does not affect the concentration of glucose in the blood plasma in patients with diabetes mellitus. Nevertheless, caution should be exercised in the treatment of these patients, since Nebilet can mask certain symptoms of hypoglycemia (eg, tachycardia) caused by the use of hypoglycemic agents for ingestion and insulin.Control of the concentration of glucose in the blood plasma should be carried out 1 time in 4-5 months (in patients with diabetes mellitus).

With hyperthyroidism, beta-adrenoblockers can mask tachycardia.

Beta-adrenoblockers should be used with caution in patients with chronic obstructive pulmonary disease, as bronchospasm may increase.

Beta-adrenoblockers can increase sensitivity to allergens and the severity of anaphylactic reactions.

Impact on the ability to drive vehicles and manage mechanisms

The impact on the ability to drive vehicles and control mechanisms is not specifically studied. Studies of the pharmacodynamics of nebivolol have shown that the Nebilet drug has no effect on the psychomotor function. During the treatment with Nebilet (if side effects occur), care should be taken when driving vehicles and when engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Drug Interactions

With the simultaneous use of beta-blockers with blockers of slow calcium channels (verapamil and diltiazem)the negative effect on myocardial contractility and AV-conduction increases.

Contraindicated intravenous administration of Verapamil against the background of nebivolol.

With the simultaneous use of nebivolol with antihypertensive drugs, nitroglycerin, or blockers of slow calcium channels, severe arterial hypotension may develop (special caution is necessary when combined with prazosin).

With the simultaneous use of nebivolol with antiarrhythmic drugs of the 1st class and with amiodarone, it is possible to enhance the negative inotropic effect and prolong the time of excitation in the atria.

With the simultaneous use of Nebilet with cardiac glycosides, no increase in the effect on the slowing of AV conduction was detected.

Simultaneous use of nebivolol and preparations for general anesthesia can cause suppression of reflex tachycardia and increase the risk of developing arterial hypotension.

Clinically significant interactions of nebivolol and non-steroidal anti-inflammatory drugs (NSAIDs) have not been established.

The simultaneous use of nebivolol with tricyclic antidepressants,Barbiturates and phenothiazine derivatives can enhance the antihypertensive effect of nebivolol.

Pharmacokinetic interaction

With the simultaneous use of nebivolol with drugs that inhibit serotonin reuptake, or other biotransforming drugs involving the isoenzyme CYP2D6, the concentration of nebivolol in the blood plasma increases, the metabolism of nebivolol slows, which can lead to the risk of bradycardia.

With simultaneous use with digoxin, Nebilet does not affect the pharmacokinetic parameters of digoxin.

With the simultaneous use of Nebilet with cimetidine, the concentration of nebivolol in the blood plasma increases.

Simultaneous use of nebivolol and Ranitidine does not affect the pharmacokinetic parameters of nebivolol.

With the simultaneous use of nebivolol with nicardipine, concentrations of active substances in the blood plasma increase slightly, but this has no clinical significance.

Simultaneous reception of Nebilet and ethanol (alcohol), Furosemide or hydrochlorothiazide does not affect the pharmacokinetics of nebivolol.

Clinically significant interactions of nebivolol and Warfarin have not been established.

When joint use of nebivolol with insulin and hypoglycemic agents for oral administration may mask symptoms of hypoglycemia (tachycardia).

Analogues of the drug Nebilet

Structural analogs for the active substance:

• Binelol;
• The nebivator;
• Nebivolol;
• Nebivolol hydrochloride;
• Nebikor Adifarm;
• Nebilan Lannacher;
• Niebelong;
• Non-attendance;
• OD of the Sky.

Analogues for the pharmacological group (beta-blockers):

• Anaprilin
• Arutimol
• Athenobene
• Atenova
• Atenol
• Atenolol
• Atenosan
• Acecor
• Betacard
• Betaxolol
• Betalock
• Betoptik
• Betofan
• Biprol
• Bisocardium
• Bisoprolol
• Breviblock
• Vasocardine
• Vicin
• Glaumol
• Inderal
• Concor
• Concor Cor
• Corbis
• Corvitol
• Korgard
• Cordanum
• Cordinorm
• Coronal
• Xoneph
• Cusimolol
• Lokren
• Metocardium
• Methanol
• Metoprolol
• Nebivator
• Niebelong
• Obsidan
• Okumed
• Okumol
• Optimol
• Prinorm
• Propranolobene
• Propranolol
• Sandonorm
• Sectral
• Sotaleks
• Timolol
• Timothy
• Tracicore
• Trimepranol
• Celiprol
• Egilok
• Egilok Retard.

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